Colorado U.S. Senator Michael Bennet joined his colleagues in the Senate today to give final approval to a bill that will modernize the Food and Drug Administration (FDA). The FDA Safety and Innovation Act along with several Bennet-sponsored measures will be sent to the White House to be signed into law. The bill passed on an overwhelming bipartisan vote of 92 to 4.
“Families in Colorado and across the country want and deserve to know that the medicine in their homes is going to help them get better, not cause harm,” Bennet said. “This bill makes long-awaited changes to outdated regulations and allows the FDA to focus on the safety and quality of the drugs and therapies Coloradans use every day. It also creates a process to get new life-saving treatments to patients faster and supports continued research and innovation in the bioscience sector, which is growing in Colorado.”
As a member of the Senate Committee on Health, Education, Labor and Pensions, Bennet worked closely with Chairman Tom Harkin (D-IA) and Ranking Member Mike Enzi (R-WY) to secure several provisions to improve drug safety, bring breakthrough treatments to patients more quickly, advance medical device innovations and prevent critical drug shortages. The final bill also includes a compromise Bennet helped craft regarding medical mobile apps. The FDA will move forward with a process to define which medical mobile apps require government attention, while the Administration will produce a report for mapping out a regulatory strategy to deal with innovation, health IT and mobile apps in the years to come.
Although during the conference process, sides came very close to consensus, a measure Bennet and Senator Richard Burr (R-NC) offered to establish a uniform, national track-and-trace framework was not included in the final bill. The senators remain committed to moving this measure forward to strengthen our nation’s drug supply chain.
Bennet’s work on the bill was the result of numerous discussions with doctors, patients, families, and other stakeholders who detailed their stories about why FDA regulations need updating.